MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2012-03-21 for CONVEEN OPTIMA 2203001001 manufactured by Coloplast A/s.
[19335872]
Two products were returned for evaluation. A peel test was performed on the device and was within the specification. The user stated that the injury occurred due to using a product that was too small. Seeing that the returned product performed according to device specifications it was concluded that human error contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[19417316]
Date of event: best estimate (b)(6) 2012. According to the information received, a user developed a bleeding skin wound after using a urisheath. The user stated that the wound was caused by using a sheath size that was too small. The user applied cream to the wound to help it heal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006606901-2012-00007 |
| MDR Report Key | 2498838 |
| Report Source | 01,04 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-02-21 |
| Date Mfgr Received | 2012-02-21 |
| Device Manufacturer Date | 2011-12-07 |
| Date Added to Maude | 2012-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | COLOPLAST HUNGARY KFT COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR, HU 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 4300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVEEN OPTIMA |
| Generic Name | MALE EXTERNAL CATHETER-UROSHEATH |
| Product Code | EXJ |
| Date Received | 2012-03-21 |
| Returned To Mfg | 2012-02-28 |
| Model Number | 2203001001 |
| Catalog Number | 2203001001 |
| Lot Number | 3082921 |
| Device Expiration Date | 2016-12-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-21 |